Cesarean DeliveryPhase 2NCT03236324
Transversalis Fascia Plane Blocks for Analgesia Post-cesarean Delivery
A Phase 2 study testing ultrasound-guided nerve block, Saline and Bupivacaine-epinephrine in people with Cesarean Delivery, run by University of Calgary at 1 site in Canada.
Trial summary
The aim of this study is to assess the efficacy of a bilateral TFP block in parturients undergoing cesarean delivery (CD) by evaluating postoperative opioid consumption and numeric rated pain scores in two groups (TFP block with saline (control) and TFP block with local anesthetic (treatment)). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- ultrasound-guided nerve block, Saline and Bupivacaine-epinephrine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- 22 Sep 2017to 11 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- elective Cesarean delivery with spinal anesthesia at South Health Campus
- term gestation with a singleton pregnancy
- American Society of Anesthesiologists' (ASA) physical status Class 1-3
Who cannot join
- language barrier
- body mass index (BMI) > 40 kg/m2
- multiple gestations
- chronic pain
- opioid use
- substance abuse
- allergies to study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ultrasound-guided Transversalis Fascia Plane Blocks for Post-cesarean Section Analgesia: a Randomized Double Blinded Control Study
The aim of this study is to assess the efficacy of a bilateral TFP block in parturients undergoing cesarean delivery (CD) by evaluating postoperative opioid consumption and numeric rated pain scores in two groups (TFP block with saline (control) and TFP block with local anesthetic (treatment)). Women (American Society of Anesthesiologists physical status Class 1-3) at term gestation with singleton pregnancies undergoing an elective CD under spinal anesthesia at the South Health Campus will be consented to participate in the study. Patients will be randomly assigned using a computer-generated table of random numbers to two groups. Group allocations will be concealed. All patients will receive spinal anesthesia with spinal Morphine according to our institutional protocol. At the end of surgery, randomized patients will receive either ultrasound-guided bilateral TFP blocks with 0.25% bupivacaine with 2.5 mcg/ml epinephrine 40 ml total or maximum 2.5 mg/kg (Group 1) or 40 mL saline (Group 2) by 2 anesthesiologists experienced in performing this block.
Read the detailed description
Caesarean delivery (CD) is one of the most commonly performed surgical procedures with an estimated annual frequency of 27% in Alberta between 2007-2011. Poorly controlled postsurgical pain is associated with an increase in morbidity. Untreated or undertreated pain can lead to respiratory infections secondary to splinting and shallow breathing. Excessive pain also reduces and delays ambulation, which can lead to both an increase in the incidence of deep vein thrombosis (DVT) and delay recovery and readiness for discharge. Poorly controlled pain may also lead to the development of chronic postsurgical pain. The optimal form of postoperative analgesia following CD is not known. Most postoperative analgesic protocols for CD, despite being multimodal in nature, rely heavily on opioid medications both orally and intrathecally for analgesia. These medications, however, are not without serious side effects such as nausea, vomiting, sedation, addiction or dependence, and respiratory depression as well as expression in breast milk which may put infants at risk of side effects as well. Thus, an effective alternative analgesic modality analgesia in these patients which produces both improved pain control and reduced side effects is desired. The TFP block represents a promising alternative, which may fulfill this role in complementing multimodal analgesia for patients undergoing CD and reducing opioid administration.
This project aims to elucidate information regarding alternative interventions for postoperative analgesia following CD. While the most common analgesic regimen of intrathecal and oral opioids, acetaminophen, and NSAIDS for postoperative analgesia is effective, it is not appropriate for all patients. For those who cannot receive intrathecal opioids (e.g. those with allergies to opioid medications, or those who are undergoing CD under general anesthetic), alternative analgesic modalities are important to provide adequate multimodal analgesia and minimize side effects of each of the analgesic medications. Additionally, this aforementioned common analgesic pathway may itself be further optimized through the addition of new analgesic techniques. The Transversalis Fascia Plane (TFP) block is a nerve block, which could potentially target nerves responsible for transmitting pain following CD, and represents a promising novel analgesic modality.
- Conditions
- Cesarean Delivery
- Being tested
- ultrasound-guided nerve block, Saline, Bupivacaine-epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided nerve blockDevice
Transversalis fascia plane (TFP) block, ultrasound-guided
SalineDrug
20 mL 0.9% saline administered on each side as bilateral TFP blocks
Bupivacaine-epinephrineDrug
20 mL bupivacaine 0.25% with epinephrine 2.5 mcg/mL to a maximum of 2.5mg/kg administered on each side as bilateral TFP blocks
| Study group | Role | What they receive |
|---|---|---|
| TFP block with saline | Placebo comparator | Placebo bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with 40 mL saline, single shot Receives: Device: ultrasound-guided nerve block; Drug: Saline |
| TFP block with local anesthetic | Experimental | Experimental bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with local anesthesic of Bupivacaine-epinephrine [0.25% bupivacaine with 2.5 mcg/mL epinephrine 40 mL (maximum 2.5 mg/kg)], single shot Receives: Device: ultrasound-guided nerve block; Drug: Bupivacaine-epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
24-hour postoperative opioid consumption presented in morphine equivalents
Measured: 24 hours
Secondary outcomes (6)
Numeric rating scale pain scores
Pain scores to be assessed at rest and movement 6, 12, 18, 24 and 48 hours post-Cesarean delivery
Measured: up to 48 hours
Time to first analgesia
Time to request of first analgesia after Cesarean delivery
Measured: 48 hours
Opioid side effects
Evaluate incidence of nausea, vomiting, pruritus, sedation after Cesarean delivery
Measured: 48 hours
Patient satisfaction
Evaluate patient satisfaction of postoperative pain relief at time of discharge
Measured: 48 hours
Quality of recovery scores
Quality of recovery (QoR-15) scores acquired preoperatively, 24 hour and 48 hours after Cesarean delivery
Measured: up to 48 hours
Post-discharge numeric rating pain scale scores
Evaluate pain scores at 30 days and 60 days after Cesarean delivery
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start22 Sep 2017
- Primary completion13 Oct 2022
- Study completion11 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236324
- Sponsor's protocol ID
- REB15-2238
- Status last verified
- May 2023
- First submitted
- 25 Jul 2017
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-guided Transversalis Fascia Plane Blocks for Post-cesarean Section Analgesia: a Randomized Double Blinded Control Study
- ClinicalTrials.gov ID
- NCT03236324
- Acronym / sponsor ID
- REB15-2238
- Conditions
- Cesarean Delivery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 13 Oct 2022 (actual)
- Study completion
- 11 Dec 2022 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the efficacy of a bilateral TFP block in parturients undergoing cesarean delivery (CD) by evaluating postoperative opioid consumption and numeric rated pain scores in two groups (TFP block with saline (control) and TFP block with local anesthetic (treatment)). Women (American Society of Anesthesiologists physical status Class 1-3) at term gestation with singleton pregnancies undergoing an elective CD under spinal anesthesia at the South Health Campus will be consented to participate in the study. Patients will be randomly assigned using a computer-generated table of random numbers to two groups. Group allocations will be concealed. All patients will receive spinal anesthesia with spinal Morphine according to our institutional protocol. At the end of surgery, randomized patients will receive either ultrasound-guided bilateral TFP blocks with 0.25% bupivacaine with 2.5 mcg/ml epinephrine 40 ml total or maximum 2.5 mg/kg (Group 1) or 40 mL saline (Group 2) by 2 anesthesiologists experienced in performing this block.
Detailed description
Caesarean delivery (CD) is one of the most commonly performed surgical procedures with an estimated annual frequency of 27% in Alberta between 2007-2011. Poorly controlled postsurgical pain is associated with an increase in morbidity. Untreated or undertreated pain can lead to respiratory infections secondary to splinting and shallow breathing. Excessive pain also reduces and delays ambulation, which can lead to both an increase in the incidence of deep vein thrombosis (DVT) and delay recovery and readiness for discharge. Poorly controlled pain may also lead to the development of chronic postsurgical pain. The optimal form of postoperative analgesia following CD is not known. Most postoperative analgesic protocols for CD, despite being multimodal in nature, rely heavily on opioid medications both orally and intrathecally for analgesia. These medications, however, are not without serious side effects such as nausea, vomiting, sedation, addiction or dependence, and respiratory depression as well as expression in breast milk which may put infants at risk of side effects as well. Thus, an effective alternative analgesic modality analgesia in these patients which produces both improved pain control and reduced side effects is desired. The TFP block represents a promising alternative, which may fulfill this role in complementing multimodal analgesia for patients undergoing CD and reducing opioid administration.
This project aims to elucidate information regarding alternative interventions for postoperative analgesia following CD. While the most common analgesic regimen of intrathecal and oral opioids, acetaminophen, and NSAIDS for postoperative analgesia is effective, it is not appropriate for all patients. For those who cannot receive intrathecal opioids (e.g. those with allergies to opioid medications, or those who are undergoing CD under general anesthetic), alternative analgesic modalities are important to provide adequate multimodal analgesia and minimize side effects of each of the analgesic medications. Additionally, this aforementioned common analgesic pathway may itself be further optimized through the addition of new analgesic techniques. The Transversalis Fascia Plane (TFP) block is a nerve block, which could potentially target nerves responsible for transmitting pain following CD, and represents a promising novel analgesic modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TFP block with saline | Placebo comparator | Device: ultrasound-guided nerve block, Drug: SalinePlacebo bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with 40 mL saline, single shot |
| TFP block with local anesthetic | Experimental | Device: ultrasound-guided nerve block, Drug: Bupivacaine-epinephrineExperimental bilateral ultrasound-guided nerve block [transversalis fascia plane (TFP) block] with local anesthesic of Bupivacaine-epinephrine [0.25% bupivacaine with 2.5 mcg/mL epinephrine 40 mL (maximum 2.5 mg/kg)], single shot |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- elective Cesarean delivery with spinal anesthesia at South Health Campus
- term gestation with a singleton pregnancy
- American Society of Anesthesiologists' (ASA) physical status Class 1-3
Key exclusion criteria (7 listed)
- language barrier
- body mass index (BMI) > 40 kg/m2
- multiple gestations
- chronic pain
- opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided nerve blockTransversalis fascia plane (TFP) block, ultrasound-guided | Device | TFP block with local anesthetic, TFP block with saline |
| Saline20 mL 0.9% saline administered on each side as bilateral TFP blocks | Drug | TFP block with saline |
| Bupivacaine-epinephrine20 mL bupivacaine 0.25% with epinephrine 2.5 mcg/mL to a maximum of 2.5mg/kg administered on each side as bilateral TFP blocks | Drug | TFP block with local anesthetic |
Primary outcome
Postoperative opioid consumption
Time frame: 24 hours
24-hour postoperative opioid consumption presented in morphine equivalents
6 secondary outcomes
Numeric rating scale pain scores
Time frame: up to 48 hours
Time to first analgesia
Time frame: 48 hours
Opioid side effects
Time frame: 48 hours
Patient satisfaction
Time frame: 48 hours
Quality of recovery scores
Time frame: up to 48 hours
Post-discharge numeric rating pain scale scores
Time frame: up to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ultrasound-guided nerve block, Saline and Bupivacaine-epinephrine in people with Cesarean Delivery, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.